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NCT01529775 Clinical Trial

Randomized Study of Osseotite Certain Tapered Prevails vs. Osseotite Certain Tapered

Partial Edentulism Clinical Trial

— Bolivar  

Official title:
A Prospective Randomized-controlled Evaluation of the Osseotite Certain Tapered Prevail Implant for the Preservation of Crestal Bone

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01529775
Other study ID # 3008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2010
Est. completion date December 2016

Study information
Verified date March 2022
Source ZimVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will demonstrate the benefits of platform switching design of the Osseotite dental implant.

Description:

The Osseotite Certain Prevail implant with its platform switch feature will demonstrate higher success rate than the non-platform Osseotite Certain implant

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients of either sex and older than 18 years of age - patients needing at least one dental implant to treat partial edentulism - patients physically able to tolerate surgical and restorative dental procedures - patients agreeing to all protocol visits Exclusion Criteria: - patients with infection or severe inflammation at the intended treatment sites - patients smoking greater than 10 cigarettes per day - patients with uncontrolled diabetes mellitus - patients with uncontrolled metabolic diseases - patients who received radiation treatment to the head in the past 12 months - patients needing bone grafting at the intended treatment sites - patients known to be pregnant at screening visit - patients with para-functional habits like bruxing and clenching

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Osseotite Certain Tapered Prevail
Osseotite implant with platform switching feature
• Osseotite Certain Tapered
Osseotite implant with non-platform switching feature

Locations
Country Name City State
Chile Universidad Finis Terrae Santiago

Sponsors (1)
Lead Sponsor Collaborator
ZimVie

Country where clinical trial is conducted

Chile, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cumulative Success Rate An implant will be considered successful if it is immobile when tested at various study time point 3 years
Secondary Crestal Bone Regression Differences in crestal bone levels obtained at various study time points will be compared between the two implant designs 3 years
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